Peridex

Description

PERIDEX™ is an oral rinse containing 0.12% chlorhexidine gluconate as the active ingredient. The Drug Identification Number (DIN) for this product is 02237452. In French, it is referred to as "Rince-bouche au gluconate de chlorhexidine 0,12 %." The formulation is designed for use in oral care, providing antimicrobial properties to help manage oral hygiene.

Uses and Indications

PERIDEX™ (Chlorhexidine Gluconate Oral Rinse 0.12%) is indicated for the treatment of gingivitis.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage of Peridex is to fill the cap to the “fill line,” which corresponds to 15 mL. The solution should be swished in the mouth undiluted for 30 seconds, twice daily, specifically after breakfast and before bedtime. After rinsing, the remainder of the solution should be expectorated.

To minimize the medicinal taste, it is advised not to rinse the mouth with water immediately following the use of Peridex. It is important to note that Peridex is not intended for ingestion and should be expelled after rinsing. Healthcare professionals may adjust the usage as prescribed based on individual patient needs.

Contraindications

Peridex oral rinse is contraindicated in individuals with a known sensitivity to chlorhexidine gluconate.

Additionally, the following instructions must be adhered to in order to ensure safe and effective use: Peridex oral rinse should not be swallowed. It is also advised not to rinse with water or other mouth rinses immediately after using Peridex. For optimal effectiveness, patients should refrain from rinsing their mouths, brushing their teeth, eating, or drinking for approximately 30 minutes following the use of Peridex oral rinse.

Warnings and Precautions

Peridex oral rinse is contraindicated in individuals with a known sensitivity to chlorhexidine gluconate.

Patients should be aware that the use of Peridex may lead to tooth discoloration and an increase in tartar (calculus) formation, particularly in areas where plaque is difficult to remove through standard brushing techniques. To mitigate these effects, it is essential for patients to maintain a rigorous oral hygiene routine, including regular dental check-ups at least every six months, or more frequently as recommended by their dentist. Both staining and tartar accumulation can be effectively managed by dental professionals.

It is important to note that Peridex may cause permanent discoloration of certain front-tooth fillings. To minimize the risk of discoloration, patients are advised to brush and floss daily, paying particular attention to areas that show signs of staining. In some instances, discoloration may be irreversible.

Patients may experience a bitter taste when using Peridex, which can also alter the flavor of foods and beverages. To reduce the impact on taste, it is recommended to use Peridex oral rinse after meals. For optimal effectiveness, patients should refrain from rinsing their mouths, brushing their teeth, eating, or drinking for approximately 30 minutes following the use of Peridex oral rinse.

No specific laboratory tests are required for the safe use of Peridex oral rinse.

Side Effects

L'utilisation de Peridex peut entraîner plusieurs effets indésirables chez les patients. Parmi les réactions les plus sérieuses, il est important de noter que Peridex ne doit pas être administré aux personnes présentant une sensibilité au gluconate de chlorhexidine, car cela pourrait provoquer des réactions indésirables graves.

Des effets indésirables communs incluent la coloration anormale des dents, qui peut également s'accompagner d'une augmentation de la formation de tartre, en particulier dans les zones où la plaque dentaire est difficile à éliminer par un brossage normal. De plus, certains patients peuvent observer une coloration anormale permanente de certains plombages des dents de devant.

Les participants aux études cliniques ont également rapporté un goût amer associé à l'utilisation de Peridex, ce qui peut altérer la saveur des aliments et des boissons. Toutefois, il a été observé que cette interférence avec le goût tend à diminuer avec un usage prolongé du produit.

Drug Interactions

Peridex oral rinse is contraindicated in individuals with a known sensitivity to chlorhexidine gluconate. It is essential for healthcare providers to assess patient history for any hypersensitivity reactions prior to prescribing this medication.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not necessary when administering Peridex oral rinse.

Packaging & NDC

Below are the non-prescription pack sizes of Peridex (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep Peridex oral rinse out of reach of children. It is important to note that Peridex is not intended for ingestion; pediatric patients must be instructed to expectorate the solution after rinsing.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Peridex (chlorhexidine gluconate rinse). As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this demographic.

Pregnancy

Peridex oral rinse is not intended for ingestion and should be expectorated after rinsing. While there are no specific statements regarding the use of Peridex during pregnancy, contraindications in pregnancy, or known risks to the fetus mentioned in the provided information, healthcare professionals should exercise caution when prescribing this product to pregnant patients. Additionally, Peridex should not be used by individuals with a known sensitivity to chlorhexidine gluconate. Given the lack of data on the safety of Peridex in pregnant women, it is advisable to weigh the potential benefits against any unknown risks when considering its use in this population.

Lactation

There are no specific warnings or recommendations regarding the use of Peridex in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided information. Therefore, healthcare professionals may consider the use of Peridex in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the drug insert for Peridex (chlorhexidine gluconate rinse). Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Peridex (chlorhexidine gluconate rinse). The prescribing information does not provide any recommendations regarding dosage adjustments, special monitoring, or precautions for individuals with compromised liver function. Therefore, healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with hepatic impairment, as the lack of data necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage of Peridex, it is crucial to note that the product is not intended for ingestion. Users are advised to expectorate the solution after rinsing to minimize the risk of accidental swallowing.

Should an individual ingest Peridex, they may experience adverse effects, although specific symptoms of overdosage have not been well-documented. In such cases, it is recommended that healthcare professionals monitor the patient for any unusual symptoms and provide supportive care as necessary.

Management of an overdosage situation should include immediate consultation with a poison control center or a medical professional for guidance on appropriate interventions. It is essential to ensure that the patient receives the necessary care to address any potential complications arising from the ingestion of the product.

Nonclinical Toxicology

Peridex oral rinse has been associated with non-teratogenic effects, including the potential for tooth discoloration and increased tartar (calculus) formation, particularly in areas where plaque is challenging to remove through standard brushing techniques. Additionally, the use of Peridex may lead to permanent discoloration of certain front-tooth fillings, with some instances of discoloration being irreversible. No information is available regarding teratogenic effects, carcinogenicity, mutagenicity, or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of Peridex oral rinse. Reports indicate that the product may lead to tooth discoloration and an increase in tartar (calculus) formation, particularly in areas where plaque is challenging to remove through standard brushing techniques. Additionally, there have been instances of permanent discoloration affecting some front-tooth fillings.

It has been noted that individuals with a sensitivity to chlorhexidine gluconate should avoid using Peridex oral rinse. Some patients have also reported a bitter taste associated with the rinse, which may alter the taste of foods and beverages; however, this effect typically diminishes with continued use of the product.

Patient Counseling

Advise patients that Peridex oral rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling, as well as to help control gum bleeding. It is essential for patients to use Peridex oral rinse regularly, as directed by their dentist, and to continue their daily brushing and flossing routine.

Instruct patients not to swallow Peridex oral rinse. Inform them that the rinse may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where plaque is difficult to remove with regular brushing. Emphasize the importance of thorough dental hygiene and regular dental visits, recommending that patients see their dentist at least every six months, or more frequently if advised.

Clarify that both stains and tartar can be removed by a dentist or hygienist. Patients should be made aware that Peridex oral rinse may cause permanent discoloration of some front-tooth fillings. To minimize the risk of discoloration, patients should brush and floss daily, paying special attention to areas that begin to show discoloration. It is important to note that in some cases, discoloration may be permanent.

Caution patients that Peridex oral rinse should not be used by individuals with a sensitivity to chlorhexidine gluconate. Additionally, inform them that the rinse may have a bitter taste and could affect the taste of foods and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, recommend that patients rinse with Peridex oral rinse after meals.

Instruct patients not to rinse with water or other mouth rinses immediately after using Peridex oral rinse. For maximum effectiveness, advise them to avoid rinsing their mouth, brushing their teeth, eating, or drinking for approximately 30 minutes after using the rinse. Encourage patients to reach out to their dentist or pharmacist if they have any questions or concerns regarding the use of Peridex oral rinse.

Storage and Handling

The product is supplied in a bottle as provided or in amber glass containers. It is essential to store the product above freezing, specifically at temperatures above 0°C, to maintain its integrity and efficacy. Additionally, it is crucial to keep the product out of reach of children to ensure safety during storage and handling.

Additional Clinical Information

Patients using Peridex oral rinse should swish the solution undiluted in their mouth for 30 seconds twice daily, specifically after breakfast and before bedtime. Clinicians should inform patients that the rinse may lead to tooth discoloration and increased tartar formation, particularly in areas where plaque is difficult to remove. Regular dental check-ups, at least every six months, are recommended to manage these effects, as both stains and tartar can be addressed by dental professionals.

Patients should also be aware that Peridex may cause permanent discoloration of some front-tooth fillings. To minimize discoloration, it is advised to maintain a thorough oral hygiene routine, including daily brushing and flossing, with particular attention to areas that show signs of discoloration. Additionally, the rinse may have a bitter taste and can alter the taste of foods and beverages; therefore, it is suggested to use Peridex after meals and to avoid rinsing, brushing, eating, or drinking for about 30 minutes post-application for optimal effectiveness.

Drug Information (PDF)

This file contains official product information for Peridex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)